CTSI Now Offers Advanced Certificate in Regulatory Science

FDA food and drug administration approval health pharmacy certification

The CTSI, in partnership with the Department of Public Health Sciences, is rolling out a new advanced certificate in regulatory science for graduate students, postdocs, and researchers from a broad range of fields. The program is just one of several efforts by the CTSI to advance regulatory science and promote student and trainee interest in learning how new drugs and devices are developed and ultimately reviewed by the Food and Drug Administration (FDA).

The NYS-approved certificate, which is a graduate credential, requires 6 courses (totaling 13 credits) covering experimental therapeutics, medical product innovation, ethics, biostatistics, FDA regulatory process, intellectual property, and science, technology and health policy. Students will also obtain at least 3 additional credits in an area of their choice, including options such as pharmacology, epidemiology, clinical trials, drug discovery, or scientific communication.

Beyond the course work, the certificate program offers mentorship and assistance in finding internships and shadowing experiences for regulatory science careers. Additionally, certificate students will participate in the annual “America’s Got Regulatory Science Talent” competition. Each year, the winner of the competition is given the opportunity to present their proposal to scientists and leaders at the FDA.

According to Scott Steele, Ph.D., associate professor of Public Health Sciences and program director for the certificate, “that exposure can give students a unique opportunity to engage leaders in this field and an advantage in identifying career paths – especially in industry or government”.

Steele believes the new regulatory science certificate program can help students with a broad range of career goals. Understanding the opportunities and challenges with medical product development and the FDA regulatory process is extremely valuable whether students plan to stay in academia or branch out into industry, government or other sectors.  This could include careers in research, policy, regulatory review, communications, program management and law.

Ultimately, the goal of regulatory science is to make the process of developing and approving new drugs and medical devices more efficient and ensuring that new, life-improving therapies can be properly and thoroughly evaluated as quickly as possible. Programs like the CTSI’s regulatory science certificate help by training scientists in the science, regulatory and policy issues involved in medical product development, creating a pipeline to the FDA, industry and other sectors.  This helps improve the efficiency and effectiveness of the translational research process by reducing the “ramp up time” for professionals in industry, academia and FDA and creating a scientifically trained workforce that is proficient in the science and policy issues that underlay the medical product development and approval process.

The certificate program applications are currently being processed for Spring 2017 but students, post-doctoral fellows, researchers and faculty can begin registering for required coursework this fall. The fall registration period for matriculated students at the University of Rochester School of Medicine and Dentistry opens July 1.

For more information and a full list of certificate requirements, click here.

Practice Root Cause Analysis at SCORE Half Day Seminar


The registration deadline to attend the 8th Annual Study Coordinators Organization for Research and Education (SCORE) Half Day Seminar is quickly approaching.  This year’s seminar will feature a simulation of root cause analysis, a methodology to review adverse events, identify key causes and contributing factors and implement system-based solutions. Recent changes to guidelines for investigation and prevention of non-compliance in clinical trials require sponsors and often research teams (study coordinators and research nurses) to be able to perform root cause analysis.

Clinical trial protocols are designed to examine specific scientific questions while minimizing risks to patient safety and maintaining data integrity.  Clinical trials have become increasingly large and complex over the past few decades. It is not uncommon for a trial to have many sites that span the nation or the globe and study teams that may change in personnel during the trial. This increased complexity leads to greater risk of errors and non-compliance, resulting in deviations from the protocol.

Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring, has set expectations that all sponsor or clinical research organization (CRO) personnel should review the monitoring plan and be prepared to perform a root cause analysis, and to implement appropriate corrective and preventative actions when deviations occur.

When things go awry in clinical research, it is essential to understand the underlying cause(s) of the error or protocol failure. Root cause analysis gets to the core of the issues, which are often related to system defects in communication, policies and processes, environment, information management and/or human resources. Depending on the root cause identified, system-based solutions are designed to reduce or eliminate the risk of the event recurring.

One thing to keep in mind is that, by their very nature, root cause analyses are not one-size-fits-all. The nature of issues and the optimal intervention will vary from site to site and from study to study. This is why it is important to do a thorough assessment of each critical issue as it arises and devise targeted solutions to prevent future issues.

To learn more about root cause analysis and the expectations for study coordinators and research nurses, register for the SCORE Half Day Seminar.

The seminar will be held on Tuesday, June 7th in the Ryan Case Method room in the URMC with live streaming available at an overflow site. Parking will be available for non-UR attendees for $6 fee.

For more information, please contact SCORE@urmc.rochester.edu.

Apply Now: Certificate of Advanced Study in Biomedical Data Science

The Clinical and Translational Science Institute and Department of Public Health Sciences are datascience_1accepting applications for the 2016 Summer cohort of the Certificate of Advanced Study in Biomedical Data Science (CAS-BDS).

Enrollment is open and classes begin on Monday, June 27.

The program, centered around a two-semester analytic project, prepares researchers to conduct “big data” analytics for health services, clinical, and public health research. This program prepares researchers for careers in data analytics, data wrangling, and clinical and health services research using large complex datasets.

“We consulted with people from industry and in academia, and looked at the state-of-the-art in terms of what people were teaching,” said Tim Dye, Ph.D., director of biomedical informatics at the CTSI. “We created this Certificate specifically to fit with all that.”

The CAS-BDS is a stackable data analytic credential for researchers and analysts with biomedical, computer science, statistical, or health service backgrounds. The curriculum draws on a range of courses that cover the fundamentals of disease biology, health care systems, and big data management and analytics.

Coursework begins with an intensive summer session that will give researchers a solid background in data science, data management, human biology, and team science. About a half dozen courses are new, having been created specifically for CAS-BDS.

“It’s pretty intense — starting with a summer Boot Camp that familiarizes everyone with the basics,” said Dye, who worked with faculty in the Institute for Data Science and elsewhere to make sure the Certificate complements other university data science offerings. “But we thought all these topics were required to have a good foundation in data science applied to the biomedical area.”

Several possibilities exist for the two-semester mentored project, which can have a basis in basic science, clinical work, health services, population health, or other fields. Projects will include attention to specific aim formulation, background, analytic plan development, database creation, data analysis, and reporting.

For more information on the CAS-BDS, visit https://urmc.rochester.edu/biomedical-data-science.aspx or contact tim_dye@urmc.rochester.edu.

Meet the winner of the 3rd Annual “America’s Got Regulatory Science Talent” competition


Joan Adamo, Angela Ryck, Martin Zand, and Scott Steele.

by Samreen Jatana
Special to CTSI Stories

Angela Ryck is the winner of the University of Rochester’s 3rd Annual America’s Got Regulatory Science Talent Student Competition Winner. She spoke with CTSI Stories about her project.Angela_Ryck_2015_v2-100x150

Could you tell me a little bit about your background and what got you interested in the competition?

I went to the University of Notre Dame for my undergraduate studies and I majored in Science Business, which was one of the pre-med tracks. In 2013, I went to Washington D.C. to do my Masters in Public Health at George Washington University (GW). Last July, I came to the University of Rochester to do another Masters degree in Biomedical Engineering through the CMTI program (Center for Medical Technology and Innovation). One of the requirements of the program is that we take the Pathways to Medical Innovation course, which is taught by Joan Adamo, Ph.D., who organizes this competition along with Scott Steele, Ph.D. It is through the Pathways class that I became familiar with the competition. We had to actively think about a Regulatory Science topic throughout the semester and come up with an innovative idea to address a particular problem.

What was the format of the competition? Could you discuss the structure of it?

They did not give us any strict guidelines to follow, which was great. But the basis was that the FDA set up eight priority areas in 2011 specifying the issues that they really want to address. For the competition we had to choose one priority area and devise a solution to address it. We were not required to write a proposal or perform any sort of study for this purpose; it was quite open-ended in terms of how we could choose to present our ideas. The competition was open to teams or individuals, and I chose to work independently. We had just five minutes to present our ideas to the three judges.

Which priority area did you focus on? Could you talk about the ideas you presented in your talk?

I addressed FDA’s 7th priority area, which is focused on enhancing medical counter measures, referred to as MCMs. Broadly speaking, these are the tools that we use to address situations including chemical threats or food that is contaminated or not safe. Within that area I focused on enhancing emergency communication, which I geared specifically towards food safety. To enhance emergency communications, the FDA wants to first assess past communications to see specifically where improvements are needed.  My idea was a sort of two-fold system that improves on the present while also assessing past communications; I called it the “ESCAPE” System. This is an acronym for “Emergency Situation Communication and Preparedness Evaluation”. To enhance current communications, it involves a universal card (the ESCAPE Card) that could be used at a wide range of stores or restaurants when a person buys food. That card will be linked to their contact information such as phone number or email. That way, in the event of a recall, those who purchased the recalled item can receive direct notification such as a text or phone call.
Stores like Wegmans and Costco are already doing exactly this, but it is not yet widespread or used by restaurants. Often people receive news of a recall via TV news or Internet, but this could make it more personalized and thus more effective. This will not only allow faster communication but will relieve people from anxiety if they were not involved in a certain recall case.  Aside from this, people will still need an incentive to participate.  Discounts and rewards systems tied to participating stores and restaurants could serve that purpose; and in return those stores and restaurants could retain some customer loyalty and perhaps some useful marketing information.

For the second aspect of assessing past communications, I designed a community-level evaluation to be used across the country. It would be a short series of questions answered online and part of the activation process when users first receive their ESCAPE card. The data collected could help the FDA to get a sense of how people in different geographical areas have received and/or understood past communications, and could also help to identify trends in health literacy. I was interested in this because of a previous experience of mine. During my masters in public health at GW, I interned for the Center for Disease Control & Prevention (CDC) in the State of Maine. I traveled throughout the State of Maine to conduct Rural Active Living Assessments, which look at individual communities and their capacity to promote physical activity through their facilities and programs. Getting down to the community level is important because it shows how the strengths and needs of communities can differ greatly. I applied this experience to the area of emergency communication.  Furthermore, Diana Monaco, a public affairs specialist at the FDA is a regional representative at the Buffalo office, and speaking with her was very helpful as well.

What next?

In the spring of 2016, I will travel to Maryland with Joan Adamo and Scott Steele and I will get an opportunity to present my project to the FDA. Before that I will continue to research and keep up with the news on this topic to ensure that all aspects of my proposal are in line with the goals of the FDA. Specifically, I’d like to further develop the evaluation portion of ESCAPE.

How does this competition fit into your future career goals? Do you see yourself working for the FDA at some point?

I definitely plan to work within the medical field. This competition and proposal are both in line with that. I really enjoyed this experience because it is so pertinent to what I learned during my public health degree and also very relevant to biomedical engineering. For example, you cannot design a medical device without familiarity with the FDA and the regulatory procedures. I learned a lot about the FDA during this project even though food safety is a little bit different than medical devices. Still, the ESCAPE Card concept could be applicable to medical devices as well. The idea can definitely be expanded to improve upon communication in a wide range of areas.

UNYTE Scientific Session Explores Innovative Methods for Translational Population Health Research

UNYTE, the CTSI-organized group of 18 regional biomedical research institutions, presented its latest “Scientific Session” on December 3rd. Entitled “Transforming Population Health Research: Advances, New Methods, and Community Partnerships”, the session brought together investigators from institutions across Upstate New York to share innovative methods, develop new collaborations and promote population-health research programs.  The topic ties together UNYTE’s mission of promoting translational research through cross-institutional research collaboration, and the CTSI’s increased emphasis on improving population health.UNYTE_black_v

Dr. Kevin Fiscella, recent appointee to a Dean’s Professorship, was the keynote speaker.  His talk, “Population Health Matters:  It’s About Lives, It’s About Time, It’s About Action” presented a comprehensive vision for population health. He challenged researchers to work across the translational research spectrum and through community partnerships – taking advantage of progress toward a learning healthcare system, advances in the availability of real-time data, and patient input – to improve clinical interventions, preventive care, behavioral health, socioeconomic factors and social cohesion.  Dr. Harriet Kitzman reviewed her highly successful Nurse Family Partnership program, a nationally and internationally successful model for moving from research to implementation of highly effective population-health programs and policies. Wade Norwood, a leader in the Rochester community and the Chief Strategy Officer at the Finger Lakes Health Systems Agency, demonstrated that community-identified needs and community input in all phases of the research life cycle can be the engine that drives health improvement. Kimberly O’Brien, Professor from The Division of Nutritional Sciences (DNS) at Cornell University, reviewed her department’s innovative programs and institutional infrastructure for building the bridges between population health and basic science.

The UNYTE Scientific Session distinguishes itself from a scientific symposium by providing dedicated time on the day’s agenda for informal “meetings of the minds” and cross-institutional discussions. Small group break-outs included targeted topics on community and patient engagement, novel data collection methods for research, patient-centered care and the learning healthcare system, promoting population health across the urban-rural continuum, and an extended conversation on the necessary meeting points between basic science and population health. Awards for the poster session were given:  Dr. Deirdre Schlehofer, Assistant Professor at the National Technical Institute for the Deaf at the Rochester Institute of Technology and her research team won the Faculty Poster Award for their poster “Health Perceptions of Deaf and Hard-of-Hearing Female College Students;” Sheila Bruce, BS,  Post-BA Fellow/ Research Coordinator at the Deaf Health Communication and Quality of Life Center at The Rochester Institute of Technology won the Student/Trainee Poster Award for her poster “Population Health Research with Deaf/HH Adults in USA.”

Details for the next UNYTE Scientific Session, including the topic focus, will be announced soon. If you would like to learn more about UNYTE, please visit their website, http://www.urmc.rochester.edu/ctsi/unyte/.

Scholar Spotlight: Wyatte Hall, Ph.D.

The Rochester Partnership for Deaf Postdoctoral Scholars is a joint program between the University of Rochester School of Medicine and Dentistry and the Rochester Institute of Technology National Technical Institute of the Deaf. In the video below, Wyatte Hall, Ph.D., a program scholar, discusses his field of study and Rochester’s vibrant deaf community.

Read more about the CTSI’s partnership with the National Center for Deaf Health Research.

November 14: Rochester Healthcare Deep Data Dive!

The Rochester Center for Health Informatics and the Goergen Institute for Data Science will host its inaugural Rochester Healthcare Deep Data Dive (ROCHD3) unconference in the Saunders Research Building from 8 a.m. to 5 p.m. on Nov. 14. The event is free to attend, though registration is required.

ROCHD3 is focused on bringing together healthcare data hackers, app designers, entrepreneurs, students, healthcare professionals, tech developers and individuals with new, innovative and effective uses of health data to improve patient outcomes and overall health. It will also drive topics for a Rochester Health Care Hack event next spring.

An “un-conference” is an event without the rules and structure of a classical conference. Instead, the participants create the agenda and discussions.


  • DocGraph:  Healthcare Provider Networking Graphs
  • DrugGraph:  Healthcare Provider Prescribing Practices Data
  • Associative and Graph Databases in Healthcare
  • CryptoHealth:  Using blockchain and cryptocurrency methods for health data
  • Twitter Healthcare applications
  • Big Data Visualization
  • Network and Graph Theory

The “ungenda”

  • Registration and breakfast begins at 8 AM with plenty of coffee and networking
  • Event kick off promptly at 9am
  • What is Healthcare Data? 4 slides x 4minutes (4×4’s) from the Sponsors
  • Lunch and more networking will be around 12:30pm
  • Breakout discussions for most of the afternoon
  • Group 4x4s in the Auditorium around 3:30pm
  • Wrap up will be at 4:30pm
  • Post HD3 libations at College Town (Beer Market) around 5:00 PM

Click here to register; for more information, contact RobertJ_White@urmc.rochester.edu.

CTSI Seminar Series hosts guest speaker from FDA

Carol Linden, Ph.D.

Carol Linden, Ph.D.

Carol D. Linden, Ph.D., Director of the Office of Regulatory Science and Innovation within the U.S. Food and Drug Administration (FDA) will present at the CTSI Seminar Series from noon to 1 p.m., Tuesday, Sept. 15, in Helen Wood Hall Auditorium.

Linden, who serves in the Office of the Chief Scientist, Office of the Commissioner, oversees a broad array of intramural and extramural programs that focus on bringing scientific and technological advances – and the education surrounding the regulation of these products – to the American public.

Her seminar will highlight some of the FDA’s initiatives to promote regulatory science, including through external partnerships. Largely, these partnerships focus on how the FDA can identify and integrate emerging scientific developments into the regulatory process to ultimately improve the development and approval of safe and effective medical products.

The lecture is part of the the Fall CTSI Seminar Series, which is themed “Advancing Regulatory Science and Translational Science: Research, Training and Partnerships.” Lunch will be served, but please bring your own beverage.

CTSI Success Stories: Research Help, other CTSI resources, makes life easier for study coordinators

Elizabeth Werner, senior health project coordinator, and Ann Marie Scorsone, senior human subject research coordinator, have utilized CTSI resources for several of their research studies with the Division of Neonatology. They recently spoke to CTSI Stories about their experiences.


Elizabeth Werner, left, and Ann Marie Scorsone, right.

Thanks for taking the time to chat! Tell us a little bit about your work and how you came to use the resources within the CTSI.

Werner: We’re research coordinators in the Neonatal Intensive Care Unit (NICU), and I’m currently doing a test with infants where we put stretchy bands around their chest and abdomen and measure whether their breathing is synchronous or asynchronous, which can have health implications. However, the band itself is not FDA approved, so our study is a device trial because the FDA wants to ensure that the babies are safe and that they won’t be harmed by this.

I’ve personally used the Research Help Desk for their clinicaltrials.gov support, because that site can be really hard to navigate. Carrie Dykes — and before her, Cindy Doane — have both come over and helped me through the system and have identified the problems that I’d been having.

Scorsone: I’m part of the National Institute of Child Health and Human Development (NICHD), and within that is the neonatal research network. So we currently have about 10 studies right now that we’re doing in the NICU as part of that network.

One of those studies is something we’ve been engaged in for 15 or more years: Dr. Dale Phelps’s study on retinopathy of prematurity (ROP), which is one of the leading causes of early childhood blindness or long term eye dysfunction. We’re in a Phase III FDA trial with that right now and it includes a long term follow up, so we had Ann Dozier come speak with us about research subject retention. And Dr. Dozier really helped us in Rochester come up with ideas on how to help approach the families and talk about the long term follow up right in the beginning.  We get a great follow-up rate at their 2-year visits – it’s over 90 percent – and she’s been a big help with that.

What types of suggestions did she make?

Scorsone: She talked about really understanding what gets in the way in terms of participation, and why you tend to lose people as a trial goes on. We’ve really tried to maintain contact with our families so they feel like they’re not just part of a research project, but actually a part of a family here.

Werner: We talk to people about how this is a research institute, and how things that are helping your baby today started with studies that other families have participated in, in the past. That attitude, I think, has helped shape our whole division. We’ve really worked hard over the past five years to make both the patients and the staff feel like part of a research community. One thing we have done to help this is to set up a NICU research tent at the Stroll for Strong Kids to present study information there.

Scorsone: And we also have high visibility in the NICU itself. We make sure the research team is down there, and we’re talking to families all the time – not just showing up when we need a blood draw. The idea is these people aren’t just subjects. We’re creating ties, which is what Ann had talked to us about – shaping the culture. So we present research to the staff down there, and we’ve identified nurse champions that are interested in research and want to help us. And they’ve really embraced it, because I think they can see the difference.

What other programs have you used through the CTSI?

Scorsone: I’ve been to Adam Tatro’s eRecord training, and he very graciously asked me to be part of his eRecord leadership group, so I gave a couple presentations as well. He’s extraordinary. We’ve actually had him come here and give our coordinators a private workshop because we do so much data extraction for all of our studies.

Werner: We’re working with Adam on i2b2 as well, and we’ve leaned on the CTSI for REDCap support. I have Amanda Davin on my speed dial. I also like many of the seminars that are run over there – I’ve learned a lot from those.

Have you used the Research Request Dashboard?

Scorsone: Yes. Dr. Patricia Chess was thinking about doing a pilot study of a device. There was a company potentially interested in potentially buying the patent. So that involved some techie licensing stuff that goes way beyond my coordinator role. But through the dashboard, I was just able to write “Hey, I have an investigator who wants to do this,” and they connected me with Joan Adamo.

So that was really neat, they’re able to connect you with all these resources in-house with the click of a button, and I didn’t have to struggle to figure out those protocols myself.

SCORE: Helping research coordinators connect and learn

by Nancy Needler, Special to the CTSI Stories Blog

Are you a research coordinator? This article is for you.

Do you know a research coordinator? Then please, pass this along.

Principal Investigators and research team members rely on coordinators every day. Coordinators impact the lives of research subjects and assist to provide the foundation behind the science data in the development of new clinical procedures, drugs, devices and technology to improve health care.

As a result, the University continues to recognize the professional role of the coordinator, and the CTSI is here to provide support.


The Study Coordinators Organization for Research & Education (SCORE) is a forum organized for coordinators where participants meet to share information, to collaborate to develop tools and practices, and to learn of University processes related to human subject research management. Providing support and regular networking opportunities for University research coordinators and staff, SCORE monthly events include presentation of resources and services needed for coordinating research, open discussions to share best practices and to discuss and identify resolutions to barriers in everyday study management activities.

To further support coordinators helping each other, a coordinator discussion listserv is also being developed. Soon coordinators will have this online forum for discussions with peers.

(This past June, SCORE, under the support of the CTSI and SON with OHSP and ACRP hosted the annual SCORE Half-Day Seminar for coordinators. The event, its 7th year, offered continuing education contact hours, was attended by 143 people, and 100% of those who responded to the evaluation rated the overall program as “good” to “excellent/high.”)

SCORE events are held monthly. Interested? Want to be engaged? What to learn what’s around the corner? Be sure you are on the SCORE distribution list – contact SCORE@rochester.edu. Protect your time now to attend future networking and educational events. To learn more, visit the SCORE website.

SCORE’s next forum event is scheduled for September 10th and will be listed on the CTSI calendar.

Research coordinator job series

Coordinators: You are special! This career is growing quickly and is recognized as a certified profession by the ACRP and SoCRA. A preparation review course is offered at the start of each year to the applicants for certification examinations. The Office for Human Subject Protection and the CTSI facilitate this successful course. Over the past 2 years, 33 students took the course, 12 of which were applications for taking the exam. All 12 applicants have passed their certification exam. The University encourages and supports recognition of your skills and experience through certification.

In 2014, the University, in a collaborative initiative with stakeholders (which included coordinators, hiring managers, human resources and CTSI leadership) formalized the coordinator career path in the three-level Human Subject Research Coordinator job series. When positons need to be filled, hiring managers and human resource business partners turn to this job series. Coordinators now have a career path designed specifically for their role.

Hiring managers are using UR Connected to advertise and connect with potential new hires.  Hiring managers continue to examine the information in listed coordinator profiles and contact coordinators for available positions.  Coordinators – consider entering or updating your profiles in this connection system.

Study Coordinators – your dedication to your profession is recognized.  Your knowledge is sought to improve study management operations.  You are invited to connect and learn by participating in SCORE.  For more information contact:  Together, we can raise research coordination to the highest order.